MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 105MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.405S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review / investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on an unknown date, the patient underwent removal of proximal femoral nailing system (tfna) devices due to cutout.The following devices; one (1) tfna nail, one (1) tfna helical blade, and two (2) locking screws with sizes of 50 mm and 46 mm were implanted on an unknown date.Procedure and patient outcome were unknown.Concomitant device reported: 5.0 mm titanium locking screw 50 mm (part # 458.950, lot # unknown, quantity # 1), 130 degree titanium cannulated trochanteric femoral nail advanced (tfna) nail (part # 04.037.162s, lot # unknown, quantity # 1), 5.0 mm titanium locking screw 46 mm (part # 458.946, lot # unknown, quantity # 1).This complaint involves one (1) device.This is 1 of 1 for report (b)(4).
Event or Problem Description
Updated event description to capture nail lot #: concomitant device reported: 5.0mm titanium locking screw 50mm (part # 458.950, lot # unknown, quantity # 1), 130 degree titanium cannulated tfna nail (part # 04.037.162s, lot # h601587, quantity # 1), and 5.0mm titaniium locking screw 46mm (part # 458.946, lot # unknown, quantity # 1).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Manufacturing location: elmira / packaged, sterilized and released by: monument manufacturing date: 19-jul-2019 expiration date: 30-jun-2029 part number: 04.038.405s, tfna fenestrated helical blade 105mm -sterile lot number: 12l2749 (sterile) lot quantity: 48 note: helical blade was manufactured by elmira; lot number 10l9185.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16457 supplied by sterigenics was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent removal of proximal femoral nailing system (tfna) devices due to cutout.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 105MM - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9336003
• Report Number: 2939274-2019-62261
• Device Sequence Number: 2448896
• Product Code: HSB
• UDI-Device Identifier: 10886982099310
• UDI-Public: (01)10886982099310
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.405S
• Device Catalogue Number: 04.038.405S
• Device Lot Number: 12L2749
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/19/2019; 12/10/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/10/2019; 12/23/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE; 5.0MM TI LOCKING SCREW 46MM- FOR IM NAILS; 5.0MM TI LOCKING SCREW 50MM- FOR IM NAILS; 11 MM/130 DEG TI CANN TFNA 420 MM/RIGHT - STERILE; 5.0 MM TI LOCKING SCREW 46 MM- FOR IM NAILS; 5.0 MM TI LOCKING SCREW 50 MM- FOR IM NAILS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 100